Methods for collecting body fluids

ABSTRACT

A method for collecting fluids present at the body of a human being or animal. An enclosure is temporarily situated at a cavity of the body, this enclosure having within itself a hollow interior for receiving a body fluid while shielding the body from the interior of the enclosure and while a part of the enclosure is situated at the body cavity in proximity to a location where a body fluid which is to be collected is situated. The enclosure carries a transfer structure which creates between the interior of the enclosure and the above location of the body fluid conditions for only inward transfer of the body fluid from this latter location into the interior of the enclosure, the inward transfer conditions being maintained effective during at least part of the time while the enclosure remains at the body cavity. Thereafter, when the enclosure is separated from the body cavity, the desired body fluid will be situated in the interior of the enclosure.

CROSS REFERENCE TO RELATED APPLICATION

The present application is a continuation-in-part of copending patentapplication Ser. No. 534,893, filed Dec. 20, 1974, now U.S. Pat. No.3,998,211, which in turn is a continuation-in-part of Ser. No. 499,925filed Aug. 23, 1974, now U.S. Pat. No. 3,934,575 and Ser. No. 499,926filed Aug. 23, 1974, now U.S. Pat. No. 3,924,607, which latter twoapplications are divisions of Ser. No. 329,862, filed Feb. 5, 1973, nowU.S. Pat. No. 3,842,166, said last mentioned application basicallyteaching the introduction into a body cavity of a device which collectsfluid from the cavity while therein and retaining the fluid afterremoval from the cavity so that the collected fluid can be analyzed,tested, or the like.

BACKGROUND OF THE INVENTION

The present invention relates to methods for collecting body fluids.

Thus, the present invention relates to methods for collecting at a bodycavity of a human being or animal body fluids which may contain certainmicroorganisms, so that in this way it is possible to determine thepresence of certain microorganisms.

At the present time when the presence of a given microorganism issuspected at a given part of the body of an individual, in order todetermine whether or not in fact such a microorganism is present, it isconventional to transfer a body fluid which is suspected of carrying themicroorganism to a suitable growth medium where the microorganism, if infact it is present, will grow so that by inspection of the growth mediumthe presence or absence of the microorganism can be determined. For suchpurposes it is conventional to apply a swab to a part of the body wherethe presence of a given microorganism is suspected, this swab removingpart of the body fluid such as mucous or the like which is suspected ofcarrying the microorganism, and then the swab is placed in contact witha suitable nutrient for transferring the body fluid with the suspectedmicroorganism therein to the nutrient medium. Thereafter the nutrient isplaced, for example, in a suitable incubator for a given period of timein an atmosphere which is favorable for growth of the microorganism, andafter elapse of this period of time, the growth medium is inspected todetermine whether or not in fact the suspected microorganisms have grownand are therefore present in the body.

Procedures and devices of the above type have inherent disadvantages.Thus, there is a considerable inconvenience in requiring a physician orother skilled individual to extract from the body of an individualmaterials which are suspected of containing a given microorganism andthen transferring the extracted material to a growth medium which mustthen be placed in an atmosphere suitable for growth. In addition to theinconvenience of these procedures, a considerable amount of equipment isrequired, and very often physicians will mail swabs with specimensthereon to laboratories for testing. Thus, under these latter conditionsa considerable delay is involved as well as a considerable risk that themicroorganisms, if they are present, will die during the intervalbetween removal from the body and contact with a nutrient at alaboratory, for example, after transportation time has elapsed.

Also, certain microorganisms cannot remain alive when subjected even toa slight temperature change upon leaving the body.

Moreover, completely aside from the above factors, the conditions underwhich microorganisms are artificially grown cannot fail to be differentfrom the conditions which obtain in the body where the microorganism maybe located. Because of these different growing conditions, it ispossible to arrive at inaccurate results according to which unnecessarytreatments will be given to an individual or according to whichnecessary treatments will not be given.

SUMMARY OF THE INVENTION

It is accordingly a primary object of the present invention to providemethods which will avoid the above drawbacks.

Thus, it is an object of the present invention to provide methodsaccording to which it is possible to collect body fluids which, forexample, may have certain microorganisms present therein, with the bodyfluid being collected directly at a body cavity where the body fluid ispresent and in such a way that the body is shielded from the collectedbody fluid, with the latter being prevented from returning to the body.

Also, it is an object of the present invention to provide methodsaccording to which an agent is present in an enclosure to give thecollected body fluid a given condition. For example if microorganismsare present in the body fluid, the agent may be antibiotic or a nutrientwhich will provide for a given condition of the body fluid directlywithin the enclosure without any possible influence on the body.

Thus, it is an object of the present invention to provide methods of theabove type which will create no particular discomfort and which will inno way result in deterioration of the health condition of a givenindividual or animal.

It is also an object of the present invention to provide methods of theabove type which are exceedingly simple and convenient to use.

Also it is an object of the present invention to provide methodsaccording to which it becomes possible to grow cultures in a relativelysimple and inexpensive manner while at the same time maintaining fullyhygienic conditions.

It is furthermore an object of the present invention to provide methodsof the above type which lend themselves to determination of the presenceof a large variety of microorganisms in a manner which will give a clearindication of the presence or absence of the microorganisms.

According to the method of the invention for collecting fluids presentat the body of a human being or animal, there is situated at a cavity ofthe body an enclosure which has within itself a hollow interior forreceiving a body fluid while shielding the body from the interior of theenclosure and while situating a part of the enclosure at the body cavityin proximity to a location where a body fluid which is to be collectedis situated. Between the interior of the enclosure and the location ofthe body fluid at the exterior of the enclosure there are createdconditions for only inward transfer of the body fluid into the interiorof the enclosure, and these conditions are maintained effective at leastpart of the time while the enclosure remains at the body cavity, so thatthereafter when the enclosure is separated from the body cavity thedesired body fluid will be situated in the interior of the enclosure.

BRIEF DESCRIPTION OF DRAWINGS

The invention is illustrated by way of example in the accompanyingdrawings which form part of this application and in which:

FIG. 1 is a sectional elevation of one embodiment of a structure forcarrying out the method of the invention;

FIG. 2 is a longitudinal sectional elevation of a structure forsupporting the device of FIG. 1 and for introducing the same into a bodycavity;

FIG. 3 is a sectional elevation of another embodiment of a device of theinvention;

FIG. 4 is a sectional elevation showing structures similar to that ofFIG. 2 for introducing the device of FIG. 3 into a body cavity;

FIG. 5 is a schematic sectional elevation of a further embodiment of adevice of the invention shown in phantom lines in a compressedcondition;

FIGS. 6-8 are respectively schematic sectional elevations of variouspossible embodiments of the invention with means for initially holdingthe enclosures in a compressed condition of restricted interior volume;

FIG. 9 is a schematic elevation of a structure of the invention whichoperates in a manner similar to that of FIG. 3;

FIG. 10 is a schematic elevation of a further variation of an embodimentof the invention as illustrated in FIG. 1;

FIG. 11 is a schematic elevation showing in section a further embodimentof the invention utilizing a dry nutrient;

FIG. 12 is a sectional elevation of a further embodiment of theinvention which is similar to the embodiment of FIG. 1;

FIG. 13 shows a variation of the embodiment of FIG. 12 which is adaptedto have a predetermined gaseous atmosphere generated;

FIG. 14 shows a further variation of an embodiment similar to that ofFIG. 8; and

FIG. 15 illustrates the manner in which any of the embodiments of theinvention can be packaged.

DESCRIPTION OF PREFERRED EMBODIMENTS

Referring first to FIG. 1, there is illustrated therein an enclosuremeans 20 in the form of an elongated container 22 made of a suitableclear, transparent plastic such as polyethylene which may be relativelysoft so that it has a certain amount of flexibility, although thislatter property is not essential with the embodiment of FIG. 1. Theopposed ends of the elongated enclosure means 20 are provided with apair of opposed closure plug means 24 which close openings formed in theplastic container 22, in the manner illustrated in FIG. 1. These plugs24 may be made of a material such as rubber or any other suitableplastic. Thus it will be seen that the enclosure means 20 is completelyclosed. However, before this enclosure means 20 is completely closed anangent such as a nutrient means 26 is situated therein. This nutrientmeans 26 may be in the form of a suitable broth which can be in itsentirety in the form of a liquid although it can also be absorbed in asuitable medium such as cotton fibers and can have any desiredviscosity. The composition of the nutrient means 26 is well known inconnection with growth of cultures, this nutrient means 26 being capableof growing a culture from microorganisms which are placed in contactwith the nutrient means 26.

In accordance with the method of the invention the enclosure means 20 isintroduced into a body cavity in such a way that the upper part of theenclosure, as viewed in FIG. 1, is situated at a body cavity in closeproximity to a location where there is a body fluid in which, forexample, it is suspected that certain microorganisms are present. Withthe method of the invention after this enclosure and nutrient thereinare situated in the above manner in the body cavity, conditions arecreated for transferring a body fluid from the location where thepresence thereof is encountered into the interior of the enclosure meansinto engagement with the nutrient means therein. These conditions arecreated in the embodiment of FIG. 1 by way of an elongated filament orstring 28 which passes completely through the plugs 24 whilefrictionally engaging the same. Thus it will be seen that while thefilament or string 28 passes through the closure plugs 24 neverthelessthe interior of the enclosure 22 remains closed. At the upper part ofthe enclosure 20 which is situated in the vicinity of the body fluid,the string 28 carries a means 30 for receiving a body fluid if indeed itis present at the location where the upper end of the enclosure of FIG.1 is situated. This means can take the form of a suitable wick or otherabsorbent medium connected to the outer end of the filament 28 which isshown at the top of FIG. 1. For this purpose it is only necessary toabraid the filament 28 so as to fray the outer end portion thereofsituated above the enclosure means 20, as viewed in FIG. 1, and in thisway a part of the filament itself forms the means 30 for receiving thebody fluid if it is present. Thus this means 30 will engage mucous orthe like which may contain the suspected microorganism, so that in thisway the microorganism is received by the means 30.

With this structure of the invention which is shown in FIG. 1, after itis situated in the selected location, according to the method of theinvention, the monofilament 28 is pulled downwardly as viewed in FIG. 1,so that the receiving means 30 with the microorganism received therebyis pulled through the upper closure plug 24 into the interior of thecontainer 22. Once this means 30 moves through the upper plug 24 it willsimply fall to the nutrient means 26 to place any microorganism in themeans 30 in contact with the nutrient means. The operator can feel thereduction in the force required to pull the string 28 as soon as themeans 30 moves into the interior of the enclosure beyond the upperclosure plug 24, so that the operator will then know that no furtherpulling of the string 28 is required. If desired, however, the string 28can be pulled completely through the lower plug 24 also so that theoperator can completely remove the string 28 if so desired.

It is to be noted that the container 22 is provided at the region of itslower end with an exterior groove 32 capable of receiving one end regionof a string which can be fastened at the groove 32 to the enclosure 22so that through such a string it is possible in any event to separatethe enclosure from the body cavity.

This structure is permitted to remain in the body cavity for a length oftime sufficient for the culture to grow, and thereafter it is removedand the culture medium can be inspected directly through the clearplastic material to determine the presence of certain microorganisms.Also, through one or both of the plugs 24 the nutrient means 26 isaccessible for application of suitable staining mediums, for example,which can aid in recognizing certain microorganisms.

Referring now to FIG. 2, it will be seen that the entire device 20 ofFIG. 1 is situated within a cupshaped body 34 made of a soft materialsuch as a suitable foam polyethylene, for example. Both the cup-shapedbody 34 as well as the container 22 are of a circular cross section, andthe cup-shaped body 34 has a top open end, as viewed in FIG. 2, wherethe top end of the container 22 is exposed so that the portion 30 of thefilament 28 will also be exposed. The cup-shaped body 34 is introducedinto the body cavity with the device 22 seated in the cup-shaped body inthe manner illustrated in FIG. 2, so that by way of the soft cup-shapedbody 34 there will be no discomfort to the individual.

In order to be able conveniently to introduce the device of theinvention into a body cavity, the cup-shaped body 34 is situated in theinterior of an elongated outer tube 36 made of any suitable relativelyrigid cardboard, plastic, or the like. Telescoped within the outer tube36 is a pusher 38 which may be in the form of a tube having at its upperend, as viewed in FIG. 2, an inwardly directed flange 40 which willengage the bottom end of the body 34 in the manner illustrated in FIG.2.

Thus, with this construction it is possible very conveniently tointroduce the structure of the invention into a body cavity. For exampleif the portion 30 of the filament 28 is to be situated in engagementwith the cervix, then the telescoped elements 36 and 38 are operated inthe manner of conventional elements of this type used to introduce acylindrical type of tampon into the vagina during the menstrual period.Thus, the upper end of the tube 36, as viewed in FIG. 2, will beinitially introduced into the vagina, and then the pusher 38 will beadvanced to displace the cup-shaped body 34 out of the tube 36 and alongthe interior of the vagina until a resistance is felt indicating thatthe upper end of the container 22 and the part 30 of the filament 28 aresituated next to the cervix. With the cup-shaped body 34 thus held inthis way at the desired location, the operator will pull on the string28 which it will be noted extends completely through and beyond the tube38. Thus, any body fluid such as mucosa or the like situated at thecervix and carrying possible microorganisms such as those of ghonorrea,for example, or any vaginitis microorganisms, will become situated inthe portion 30 together with mucosa or the like absorbed thereby, andsuch microorganisms if they are present will be pulled together with thestring 28 through the upper plus portion 24 while the container remainsclosed. The pulling of the string in the above manner is delayed,however, until the container has been in the body for a time sufficientfor the entire assembly to assume the temperature of the body. As wasindicated above once the portion 30 of the string 28 moves inwardlybeyond the plug 24 shown at the top end of the container 22 in FIG. 1,the operator will feel reduction in the resistance to pulling on thefilament 28, and thus it will be known that the portion 30 has reachedthe interior of the container 22 and can fall freely into engagementwith the nutrient 26. If desired, however, the operator can continue topull on the string 28 so as to remove the latter completely through thelower plug 24 also. In either case, once the part 30 has engaged thenutrient 26 the tube 38 can be removed while the cup-shaped body 34together with the device 20 remains in the body so that microorganisms,if they are present, can grow in the nutrient means 26 while the lattertogether with the container 22 remains in the body.

After a given length of time it is possible to remove the body 34together with the device 20 from the body cavity. For this purpose asuitable string may be attached to the groove 32 or if the string 28remains it can be used for this purpose.

It is to be noted that with the above-described method and structure ofthe present invention it is possible to grow cultures from suspectedmicroorganisms directly in the body cavity where the presence of themicroorganisms is suspected so as to closely simulate for the growth ofthe culture the conditions which are present in the body cavity itself.In addition, because the container 22 is completely closed there is nopossibility of providing in the body itself conditions which willenhance the growth of the microorganisms in a manner which will causegreater deterioration to the body itself from the growth of themicroorganisms. Thus with the method and structure of the invention thebody is safely shielded from any possible ill effects resulting fromgrowing the microorganisms in the body itself.

As was indicated above, once the cups 34 is removed it is a simplematter to remove the device 22 and then carry out whatever steps arerequired to determine whether or not a culture growth in the nutrient 26contains the suspected microorganisms.

A further variation of the structure of the invention is shown in FIG.3.

According to this embodiment the device 42 is in the form of a containersimilar to the container 22 made of the same material. However in thiscase the device 42 has a closed bottom end 44, as viewed in FIG. 3,while the upper end 46 is formed with an elongated opening 48 which isof a relatively small diameter. This opening 48 is lined with anelongated plastic or glass tube 50 which has compressed in its interiora wick 52, as illustrated in FIG. 3. This wick 52 has an upper free endportion which projects beyond the upper end of the container 42 in themanner shown in FIG. 3. Moreover the entire container is seated in acup-shaped body 34 which is identical with that of FIG. 2. However itwill be noted that in FIG. 3 the groove 54 which corresponds to thegroove 32 of FIG. 1 has a string 56 situated therein and extendingthrough and behond the soft cup-shaped body 34 in the mannerillustrated.

This structure which is shown in FIG. 3 is seated in an outer tube 36 inthe manner shown in FIG. 4 with a pusher 38 being provided as was thecase with FIG. 2. Thus the embodiment of FIG. 3 can be introduced into abody cavity in the same way the embodiment of FIG. 1. In this case,however, the cup-shaped body 34 together with the device 42 is simplyplaced in the body cavity with the upper free end of the wick at theupper part of the container 42 being situated at the region where thepresence of certain microorganisms is suspected. After the length oftime required for growth of a suitable culture the entire device 42together with the body 34 are removed by pulling on the string 56.

It is to be noted that the embodiment of FIG. 3 will operate in aparticular manner. Thus, the wick 52 by being compressed within the tube50 which in turn has a sealed engagement at its outer surface in theopening of the part 46 of container 42 serves to substantially close thecontainer while at the same time permitting by the absorbent action ofthe wick a body fluid with suspected microorganisms therein to passthrough the wick into the interior of the container 42 where thenutrient 58 is situated. This body fluid with suspected microorganismstherein will form at the lower interior end of the wick, as viewed inFIG. 3, a drop which will separate itself from and fall from the wick tothe nutrient medium 58. As successive droplets of body fluid withsuspected microorganisms therein fall from the wick the level of thenutrient medium, which may be a liquid broth, for example, will arisetoward the wick thus reducing the interior space above the liquidmaterial in the interior of the container 42. In this way the pressureof the latter space will increase to limit the extent to which thedripping of the body fluid into the interior of the container 42 cantake place. The plastic or glass tube 50 prevents any liquid which maybe situated in the interior of the container beside the wick fromengaging the latter. At the same time, because of the increased pressurein the space above the liquid in the container 42 the dripping will stopbecause an equilibrium will be reached when the pressure becomes greatenough to prevent any further fluid from entering through the wick, andthus in this case also there is provided a container capable of growinga culture in its interior without in any way contaminating the body inwhich the device of the invention is situated.

As was the case with FIG. 1, the device of FIG. 3 is removed after agiven time and then suitable procedures can be carried out with respectto the nutrient to determine whether or not any culture which growstherein contains suspected microorganisms.

Referring now to FIG. 5, there is illustrated therein a device 60according to the present invention, this device being capable of beingintroduced into a body cavity by way of an outer tube and an innerpusher as was the case with the embodiments of FIGS. 1 and 3. However,in this case the device 60 is made of a flexible clear plastic materialsuch as a suitable relatively soft polyethylene. In this way the device60 is provided with a container 62 which is flexible as well as beingresilient to a substantial extent.

In its lower end region the container 62 encloses a nutrient means 64which may be in the form of a broth having suitable nutrients therein,and this nutrient medium may be contained in a suitable absorbentfilamentary structure if desired. As was the case with the embodimentsof FIGS. 1 and 3, the nutrient medium may also have in it antibioticsfor preventing the growth of microorganisms in which there is nointerest and the presence of which may render identification ofsuspected microorganisms more difficult to carry out.

The upper part of the container 62 of FIG. 5, which forms the upper partthereof when it is introduced into a body cavity, is formed with arelatively short neck 66 having a narrow bore 68 of small diameterpassing therethrough. At its inner surface, the container 62 carries aflap valve 70 which is capable of opening to permit fluid to enter theinterior of the container 62 but which closes if fluid tends to flow outof the container 62. This flap valve 70 is thus in the form of a simpleleaf of plastic material joined at one edge in a suitable way to theinner surface of the container 62. It is to be noted that the container62 as well as the containers of FIGS. 1 and 3 and those described belowmay originally be in the form of a pair of half shells which are joinedtogether at a suitable seam or they may be split initially between theiropposed ends and then joined circumferentially, so that it is a simplematter to introduce into these containers the desired materials beforethe containers assume the configuration disclosed in the drawings.

When the neck portion 66 of the container 62 is formed as by molding inan injection mold, for example, this part of the container is moldedaround a magnetic body 72 made of any suitable magnetic alloy, forexample, and having the configuration of a ring or the configuration ofa pair of opposed relatively small magnetic bodies. The body or bodies72 are initially provided in a known way with a fairly substantialmagnetic force. Moreover, there is situated in the interior of thecontainer a small spherical body 74 also made of a magnetic material andadditionally provided with a substantial magnetic force, the polarity ofthe body 74 having with respect to the polarity of the body or bodies 72a relationship according to which the body 74 is attracted toward thebody 72. In order to prevent contamination of the nutrient 64 by themetallic material of the body 74, it is embedded in a covering of inertplastic material 76.

Initially the above-described structure is held with the flap valve 70displaced to a position opening the bore 68, for example by insertingthrough the bore 68 a rod of extremely small diameter holding the flapvalve 70 in at least a slightly open position in opposition to themagnetic force tending to close the flap valve by the attraction betweenthe body 74 and the magnetic means 72. With the parts held in thisposition the interior of the container 62 is evacuated in any suitableway so that the container is in a compressed condition of restrictedvolume as shown in dotted lines in FIG. 5. Thus the evacuation of theinterior of the container 62 will cause the outer atmosphere to compressthe container 62 so that it will assume the dotted line configurationillustrated in FIG. 5, and when the container 62 has been compressed tothe desired extent in this manner the small pin which holds the flapvalve 70 in its slightly open position is withdrawn so that the flapvalve 70 now closes and the magnetic valve means serves to maintain theflap valve in its closed position so that initially the parts have thecondition shown in dotted lines in FIG. 5.

It is in this condition that the structure is introduced into a bodycavity in the manner described above in connection with FIGS. 1-4, andof course when the embodiment of FIG. 5 is introduced into the bodycavity the neck 66 is placed at its outer free end in engagement withthe part of the body where it is suspected that certain microorganismsare present.

With the device 60 of FIG. 5 thus situated in the desired location, thebodies 72 and 74 are demagnetized in a well known manner, simply bysituating a suitable electrical field at the exterior of the body of theindividual in the region of the magnetic bodies 72 and 74. Thisreduction in the magnetic force will permit the flap valve 70 to openwhile the walls of the container 62 expand to the solid line conditionillustrated in FIG. 5, with the result that a certain quantity of bodyfluid which may have suspected microorganisms therein is drawn throughthe bore 68 into the interior of the container 62. Thus the container 62will assume a solid line position shown in FIG. 5 and a certain quantityof body fluid with suspected microorganisms therein will be situated inthe interior of the container in engagement with the nutrient 64. Ofcourse, any tendency of fluid to flow out of the container will beprevented by the flap valve 70, so that an effective means is providedto prevent a reversal of the flow thus localizing all growth ofmicroorganisms to the interior of the container without any possibledanger to the individual.

In this case also after a predetermined length of time the container 62will be removed and the nutrient medium will be inspected to check onthe presence or absence of suspected microorganisms.

Of course the device 60 of FIG. 5 may be situated in a suitablecup-shaped supporting body as described above in connection with FIGS. 2and 4, and a suitable string may be attached to the container of FIG. 5to facilitate withdrawal thereof from the body cavity.

Referring now to FIG. 6, the embodiment of the invention illustratedtherein also includes a device 80 having a flexible resilient container82 made of a clear plastic as was the case with FIG. 5. However, in thecase of FIG. 6 the container 80 is only provided at its upper end, whichbecomes situated uppermost when situated at the body, with a slit orwith a minute pinhole type of opening 84. A nutrient means 86,corresponding to any of the nutrient means referred to above, issituated in the container 82 as illustrated.

According to this embodiment there is also an outer tube 88 throughwhich the device 80 is pushed into the interior of the body cavity inthe manner described above in connection with FIGS. 2 and 4. However, inthis case the outer tube 88 is provided at its interior with a bulgingportion 90 which serves to deform the container 82 in the mannerillustrated in FIG. 6, so that in this way the container 82 has arestricted interior volume. The pusher which is used with the outer tube80 differs from the pusher of FIGS. 2 and 4 in that this particularpusher will have a portion which is cut away so as to clear the bulgingportion 90 while the pusher displaces the container 82 past the bulgingportion 90. The result is that the container 82 is introduced into thebody cavity in a compressed condition of restricted interior volume. Assoon as the unit 82, however, moves beyond the bulging portion 90, itwill expand slowly due to its inherent resiliency, drawing fluid inthrough the minute opening 84, and if any of this fluid has thesuspected microorganisms they will of course contact the nutrient means86. In this case also the container 82 has a suitable string attachedthereto as, for example, a string 91 embedded in a wall of the container82 and projecting from this wall so as to be accessible for withdrawingthe container 82 after a given length of time sufficient formicroorganisms to grow in the nutrient means 86 while the containerremains in the body cavity.

Of course, with this embodiment of FIG. 6 it is also possible to situatethe container 82 in a cup-shaped body made of a soft material, as wasthe case with the embodiments of FIGS. 1-3, and in this event thebulging portion 90 would compress the soft cup-shaped body and actthrough the latter on the container 82 in order to compress the latterin the manner shown in FIG. 6. Thus with this simple embodiment of FIG.6 it is also possible to achieve an automatic expansion of the container82 when its slit 84 becomes situated at the location where it issuspected that certain microorganisms are present, so that if indeedthese microorganisms are present they will be sucked in through the slit84 into the interior of the container 82 together with any body fluidswhich carry the microorganisms.

The embodiment of FIG. 7 is identical with that of FIG. 6, except forthe fact that with the embodiment of FIG. 7 the container 82 is providedin its interior with a flap valve 92 which normally maintains the smallminute opening 84 closed but which of course is capable of turninginwardly away from the opening 84, the flap valve 92 being fixed, forexample, to the inner surface of the container 82 only at the right edgeregion of the flap valve 92, as viewed in FIG. 7. Thus, with thisembodiment, all of the features described above in connection with FIG.6 will be the same, the only difference being that the flap valve 92automatically yields to permit fluid, with suspected microorganismstherein, to enter into the container 82, while the flap valve 92 willreliably prevent any fluid from escaping from the interior of thecontainer 82. Thus with the embodiment of FIG. 7 it is possible toprovide an opening 84 which is somewhat larger than the slit 84 of theembodiment of FIG. 6.

With the embodiment of the invention which is illustrated in FIG. 8,there is also a container 82 which is identical with the container 82 ofFIG. 6. However, in this case, the container 82 is initially maintainedin a compressed condition of restricted interior volume, as shown indotted lines in FIG. 8, by way of a ring 94 which is made of a materialwhich will dissolve in the interior of the body. Such materials are wellknown. Thus, with this embodiment before the container is introduced itis compressed to the dotted line condition and maintained in thiscompressed condition by the ring 94, and then the container 82 of FIG. 8is introduced into the interior of the body cavity in the mannerdescribed above, so that the slit 84 becomes situated at the locationwhere it is suspected that certain microorganisms are present.

After the container 82 of FIG. 8 remains at the cavity of the body for agiven time, the conditions prevailing in the interior of the body cavitywill cause the ring 94 to dissolve and thus release the container 82 sothat by its own inherent resiliency it will expand back to its initialcondition shown in solid lines in FIG. 8. The result is that during thisexpansion fluids in the body cavity with suspected microorganisms inthese fluids are drawn into the interior of the container 82 of FIG. 8so as to engage the nutrient means 86 therein.

Of course, with the embodiment of FIG. 8 it is also possible initiallyto locate the device 82 in a cup-shaped body of soft material asdescribed above. However, it is to be emphasized that with theembodiments of FIGS. 6-8 as well as with those of FIGS. 1-3 it is notabsolutely essential to provide the cup-shaped body with soft material.The devices of the invention are relatively small and normally will notcreate any particular discomfort even if they are introduced without theuse of a cup-shaped body as described above. The latter may be used,however, in those cases where it is felt that a particular individualmay be particularly sensitive.

The embodiment which is illustrated in FIG. 9 is essentially the same asthe embodiment which is illustrated in FIG. 3. Thus, the embodiment ofFIG. 9 has an outer container 100 which is made of a clear flexibleresilient plastic material, this container being closed at its top endby a closure plug means 102 formed with an opening against the interiorsurface of which is located an elongated capillary tube 104corresponding to the tube 50 of FIG. 3 except that the tube 104 is of asmaller diameter so as to have the capillary action which is desired forthe embodiment of FIG. 9. With the embodiment of FIG. 9, instead of awick, which extends through the interior of the tube, there is an outerrelatively small body 108 of cotton or absorbent wadding, to engage thatpart of the body where it is suspected that certain microorganisms arepresent. A filamentary extension 106 of the wadding 108 extendsdownwardly through the interior of the capillary tube 104. A nutrientmeans 110 is situated in the interior of the container 100 at the lowerregion thereof.

It is to be noted that in this case the container 110 has theillustrated configuration according to which its largest diameter is atan intermediate portion surrounding the bottom end of the capillary tube104 where a drop forms to fall from the bottom end of the capillary tube104 to the nutrient means 110. This embodiment of FIG. 9 may also besituated in a suitable soft cup-shaped body to render greater comfort tothe individual, and when it is introduced into the body, the cottonwadding 108 will engage the part of the body where it is suspected thatcertain microorganisms are present. The body fluid will then flow downthe capillary tube to form a drop 112 as shown in phantom lines at thebottom of the capillary tube 104 in FIG. 9. Because of the largerdiameter of the plastic container 100 at the elevation of the drop 112,there is sufficient space for this drop to form while the remainder ofthe container can be maintained at smaller dimensions, and at the sametime as the level of liquid in the container builds, the pressure willincrease, as was the case with the embodiment of FIG. 3, so as to limitthe extent to which liquid will rise in the container. Thus, not only isa sufficient free space provided for the droplet in FIG. 9, but at thesame time without increasing the amount of material used for thecontainer 100 it is possible for a substantial amount of body fluid toenter so as to make certain that if any microorganisms which aresuspected are indeed present they will be contained in the container 100to grow as a result of the presence of the nutrient broth.

Of course, this embodiment of FIG. 9 also may be provided with asuitable string for withdrawing the device of FIG. 9 from the interiorof the body.

The embodiment of the invention which is illustrated in FIG. 10 may beconsidered as being identical with that of FIG. 1 and is onlyillustrated schematically in FIG. 10 for the sake of simplicity. Thus itwill be seen that there is schematically shown in FIG. 10 the container22 having the opposed closure plugs 24 through which a monofilament orstring 28 extends so that the upper roughened free end 30 of the stringcan receive a body fluid with suspecting microorganisms therein and bedrawn into the interior of the container 22.

However, with the embodiment of FIG. 10 the string or monofilament 28fixedly carries in the interior of the container 22 an inert bead 120which limits the extent to which the string 28 will be pulled. Thus whenthe bead 120 reaches the phantom line position shown in FIG. 10 inengagement with the bottom closure means 24, the abraided part 30 of thestring will surely have been introduced into the interior of thecontainer below the upper closure plug 24, so that contact between asuspected microorganism and the nutrient medium 26 is assured while atthe same time the extent to which the string 28 is pulled is limited bythe inert bead 120 which is attached to the cord 28.

In all of the above-described embodiments there is situated within thecontainer a nutrient medium which may be a suitable broth as referred toabove. As a specific example, the nutrient medium may take the form of aMueller Hinton Broth which may be present in an amount of, for example,2.1 grams for each 100 ml total broth. With this latter broth there iscontained in the total nutrient medium a certain amount of Agar whichmay be present in an amount of, for example, 0.150 grams for each 100 mlof broth. Of course, in addition to the above ingredients the remainderof the broth will be made up of water. It is possible to increase theamount of Agar for each 100 ml of total nutrient medium up to 0.200grams where the nutrient medium will start to congeal at 37° C. Thus, byvarying the amount of Agar in the nutrient means it is possible tocontrol the viscosity thereof.

In addition, as was pointed out above, the nutrient means will containcertain antibiotics for the purpose of preventing growth ofmicroorganisms in which there is no interest and the growth of which mayserve only to confuse the indication of the growth of a particularmicroorganism in which there is an interest. Such antibiotics may be thefollowing which are present in the indicated amounts:

    ______________________________________                                        Cholestimethate  0.00563    (5.6 mg)                                          Nystatin         0.0090     (9.0 mg)                                          Vancomycin       0.0025     (2.5 mg)                                          polymixin B      0.00125    (1.25 mg)                                         ______________________________________                                    

Thus, antibiotics as set forth above may be included in the nutrientmedium in the above amounts for each 100 ml of nutrient means.

The particular antibiotics referred to above will effectively kill E.coli, the growth of which might serve only to confuse the indication ofthe growth of other microorganisms.

In addition, in connection with the nutrient medium, it is to be notedthat it is not essential that this nutrient medium be in the form of aliquid. As is apparent from the above description of the severalembodiments of the invention, one of the primary advantages achieved bythe present invention is that there can only be a flow of body fluidinto the container but not out of the container, so that there can be noill effects to a particular individual. This result of the presentinvention also can be achieved with an embodiment of the invention asillustrated in FIG. 11. Thus in FIG. 11 there is disclosed a container122 which may also be made of a clear flexible plastic material throughwhich the nutrient in the interior of the container is readily visible,as is the case with all of the above-described embodiments of theinvention. However in this case the nutrient means 124 is initially dry.Thus a nutrient medium as set forth above may be absorbed by a suitableabsorbent fibrous material which is packed into the container asillustrated in FIG. 11. However, when this nutrient means 124 issituated in the container 126 of the device 122, this nutrient istotally dry. In this case the upper end of the container which is to besituated in close proximity to the region where it is suspected thatcertain microorganisms are present is formed with an opening which isclosed by a wick 128 having at its upper end a frayed portion 130 whichwill readily absorb body fluid with suspected microorganisms therein,and in this case the wick will serve to transfer the body fluid directlyto the dry nutrient means 124. With this particular embodiment of theinvention the amount of dry nutrient 124 situated in the container 126is sufficient to require a relatively long time for the nutrient 124 tobecome completely saturated. With all of the embodiments of theinvention the device may remain in the interior of the body for a periodof time which is on the order of twelve hours. Thus with the embodimentof FIG. 11 a sufficient nutrient 124 is situated in dry condition in thecontainer 126 so that a complete saturation of the nutrient 124 prior toelapse of a period on the order of twevle hours cannot take place. As aresult during the entire time that the device of FIG. 11 remains in thebody it is only possible for flow to take place toward the interior ofthe container but not toward the exterior thereof, with the esult thatthere cannot be any reverse flow out of the container of the invention,in the embodiment of FIG. 11, since the container of FIG. 11 will beseparated from the body cavity prior to the time when the nutrientmedium becomes totally saturated.

Thus, it will be seen that with embodiments of the invention as shown inFIGS. 1 and 10, the fact that the string or monofilament is frictionallypulled through the closure plugs will reliably prevent any reverse flowout of the container. In the same way, with the embodiments of FIGS. 3and 9, the building up of the pressure within the container after fluidis delivered into the latter by the wick or capillary tube will preventthe fluid delivered to the interior of the container from flowing backout of the container. Thus in the case of FIG. 3 the fluid cannot haveaccess to the wick because of the pressure which will build up in theinterior of the container while in the case of FIG. 9 the same resultsare achieved, which is to say that the pressure in the interior of thecontainer of FIG. 9 will become too great to enable the fluid deliveredinto the interior of the container to again have access to the filament106 so as to be carried upwardly along the capillary tube back to thebody. In this connection the embodiment of FIG. 9 is of particularsignificance inasmuch as the enlarged portion surrounding the area ofthe bottom end of the capillary tube 104 will prevent liquid in thecontainer of FIG. 9 from engaging the bottom end of the capillary tubeeven if it should not be precisely vertical. The same of course holdstrue for the embodiment of FIG. 3 where the outer tube 50 will preventany liquid from having access to the wick.

Of course, all of the above-described embodiments which have flap valveswill be reliably prevented by such flap valves from affording thepossibility of flow out of the container. Those embodiments which havesimply a small minute opening such as a pinhole 84, as shown in FIGS. 6and 8, are also particularly effective in this respect. Thus, it is tobe emphasized that these openings 84 are normally completely closed.They are formed, for example, by a small slit which pass through thewall of the container. As a result of the presence of such a small slit,which need not have a length greater than 1/32 of an inch, for example,during the expansion of the container the edges which form the slit willyield inwardly to permit inward flow of fluid. However, once thecontainers reach their initial configuration these slits 84 becomecompletely closed to prevent any possibility of flow of fluid out of thecontainers 82. It is to be noted in this connection that the inward flowof fluid takes place in all embodiments of the invention over arelatively long period of time which is on the order of several hours,for example from six to twelve hours. This result is achieved also byway of the slit 84 which permits the fluid to flow into the interior ofthe container only at an extremely slow rate. Thus, with the embodimentsof FIGS. 6 and 7, for example, when the containers 82 are deformed so asto push air out of the interiors of the containers, by the action of thebulges 90, these containers will not immediately resume their initialconfiguration. Because of the presence of the slit 84 it is not possiblefor air to be drawn rapidly back into the containers 82 and they remainin their compressed condition of restricted interior volume over a longperiod of time requiring several hours before the containers 82 resumetheir initial condition. The same effect of several hours of delivery offluid at an extremely slow rate to the interior of the container isachieved with the other embodiments, with the possible exception ofFIGS. 1 and 10 where the operator manipulates a string for this purpose.However it is to be emphasized that with these embodiments the operatorwill not manipulate the string to pull the suspected microorganism intothe container until after the container has remained in the body cavityfor a period of time sufficient to enable the entire device of theinvention to assume, throughout all parts of the device of theinvention, the temperature of the body in whose cavity the device isplaced. Thus, it is known from experience that one of the most seriousdrawbacks of transferring microorganisms by way of a swab from theinterior of a body to a suitable plate at the exterior of the body onwhich growth is to take place resides in the fact that themicroorganisms are of necessity subjected to a change in temperatureduring such transfer operations. A temperature change which need only beon the order of 2° may be sufficient to kill certain microorganisms sothat they will never grow and a test will be negative when in fact themicroorganisms are present in the body. It is precisely such a drawbackwhich is avoided with the present invention. Because the microorganismis drawn into the container of the invention over a long period of time,the device of the invention will be uniformly, throughout all of itsparts, at the body temperature during travel of microorganism to thenutrient in the container of the invention. This factor, of course,shows the significance of the ring of FIG. 8. The ring 94 of FIG. 8 willonly dissolve, as a result of the temperature of the body, after a givenperiod of time whereby it is assured that the device of FIG. 8 will beat body temperature before any microorganisms reach the nutrient 86.However, the same advantages are achieved with the embodiments of FIGS.1 and 10, as pointed out above, simply by delaying the pulling of thestring until after the device has remained in the body for a sufficientlength of time to assure a uniform body temperature throughout theentire device of the invention. Of course, those embodiments which havewick or capillary tubes will assure accurate indications of the presenceor absence of certain microorganisms because they continue to deliverthe fluid to the nutrient over a period of several hours.

The above-discussed important feature of the invention according towhich a reverse flow of fluid out of the container back to the body isreliably avoided is carried out, in principle, even after the device isremoved from the body. Thus it is equally important to preventcontamination of individuals who handle the device of the invention.Therefore, where inspection alone of the nutrient through the cleartransparent wall of the container of the invention will not give therequired information, it is possible to use certain dyes in order tobring out the presence or absence of suspected microorganisms with greatclarity. Such dyes are readily introduced into the interior of thecontainer of the invention without opening the container, so that theoperator need never touch the nutrient medium within the container. Forexample one or more drops of a suitable dye can be introduced by way ofa syringe the needle of which simply punctures through the wall of thecontainer to enable the required amount of dye to be dropped onto thenutrient. In addition, where there are wicks, it is possible simply toapply the dye to a wick which will draw the dye into the container inorder to spread the dye over the nutrient medium in order to give therequired indication.

In connection with the nutrient means, as indicated above, it is notessential that this nutrient means be in the form of a liquid alone,since it can be absorbed in a suitable fibrous absorbent medium and caneven be in a completely dry condition with the particular embodiment ofthe invention which is illustrated in FIG. 11 making special use of thislatter type of nutrient.

It is to be noted that in some cases the collected body fluid itselfwill form a sufficient nutrient means, so that an additional nutrientmeans need not be provided.

Referrring now to FIG. 12, there is illustrated therein an embodiment ofthe invention which is similar to that of FIG. 1. Thus FIG. 12 shows adevice 140 constructed in accordance with the present invention forcarrying out the method of the invention, this device 140 including acontainer 142 which is similar to the container 22 of FIG. 1 except thatthe container 142 does not have any plugs. The plastic material at theends of the container 142 directly engage the filament or string 28which may be identical with that of FIG. 1 and which is capable of beingpulled in the same way into the container 142 so as to engage thenutrient 26 therein. When the container 142 is formed, the shellsthereof, when joined together will directly engage the string 28 so thatthe latter is capable of being pulled through the ends of the container142. Thus it is not essential to have plugs as shown in FIG. 1.

Referring now to the embodiment of the invention which is illustrated inFIG. 13, it is desirable in connection with certain microorganisms toprovide special atmospheres in which the microorganisms will havefavorable growth conditions. For example certain microorganisms readilygrow in a carbon dioxide atmosphere. With an arrangement as shown inFIG. 13 it is possible to provide such an atmosphere. The device 144 ofFIG. 13 includes a container 146 which may be identical with thecontainer 142 of FIG. 12 and which has its end walls traversed by astring 28 in much the same way, as shown in FIG. 13. However, the topend 148 of the container 146 is formed with an opening which is closedby a plug 150, and joined to the exterior surface of the top end 148 isa small flexible enclosure 152 made of a suitable plastic and containinga liquid 154, such as acetic acid. Situated directly on the nutrient 26in the container 146 is a pellet 156 which may be a bicarbonate pellet.Just before the device of FIG. 13 is introduced into the body cavity,the flexible enclosure 152 is compressed so as to force the liquid 154into the container 146 with the plug 150 yielding at this time as aresult of the pressure applied to the container 152. When the aceticacid engages the pellet 156 there will be an automatic generation ofcarbon dioxide gas which fills the interior of the container 146 so asto provide an atmosphere which is highly favorable for the growth ofcertain microorganisms.

Except for the above distinctions the embodiment of FIG. 13 operates inthe same way the embodiment of FIG. 12.

Referring now to FIG. 14, the device 158 of the invention which isillustrated therein includes a flexible clear transparent container 160which may be identical with the container 82 shown in FIG. 8. Thiscontainer 160 also has a slit 162 at its top end, and this slit isidentical with the slit 84. However in this case of FIG. 14, when thecontainer is compressed to assume the dot-dash line condition, insteadof providing a ring 94 of dissolvable material around the centralportion of the container, as shown in FIG. 8, a simple small body 164 isplaced over the slit 162 in the manner shown in FIG. 14. This body 164is made of a material which may be the same as the material of the ring94. It will adhere to the exterior surface of the container 160 and willreliably close the slit 162 so that the container 160 will remain in itscondition of restricted volume shown in dot-dash lines in FIG. 14 aslong as the body 164 which can dissolve in the interior of the cavityremains in the position shown in FIG. 14. With this embodiment, thecompressed container is introduced into the cavity with the slit 162 ofcourse situated adjacent the region where it is suspected that certainmicroorganisms are present which should grow in the nutrient medium 86.Due to the temperature prevailing in the interior of the body cavity,the closure element 164 will dissolve and as soon as it disappears theslit 162 will become uncovered so that the container 160 can thengradually expand while drawing through the slit 162 body fluids withsuspected microorganisms therein to grow, if they are present, in themedium 86, as described above in connection with FIG. 8. Thus theembodiment of FIG. 14 will achieve the same results as the embodiment ofFIG. 8 without requiring a ring 94 as is the case with FIG. 8.

Of course, the embodiment of FIG. 14 may be provided with a removalstring similar to the string 91 of FIG. 8, and the same is true of theembodiments of FIGS. 12 and 13.

Any of the above-described embodiments of the invention may be packagedin such a way that they will have a long shelf life prior to usethereof. Thus, FIG. 15 shows a suitable package for the device 140 ofFIG. 12, but it will be understood that this package can readily be usedfor any of the above-described devices of the invention. Thus, FIG. 15shows a package 166 which has an outer layer 168 of a plastic such aspolyethylene, this outer layer 168 being lined by an inner layer 170 ofa suitable metal film such as an aluminum foil, for example. The device140, or any of the other devices of the invention, is situated in thepackage prior to sealing thereof as shown in FIG. 15. Also, the sealingof the package takes place in an atmosphere which contains an inert gaswhich will serve to maintain the desired shelf life of the device whichis packaged. For example the sealing of the package of FIG. 15 may takeplace in a carbon dioxide atmosphere, or if desired a nitrogenatmosphere may be used, so that the interior of the package contains agas which will act to preserve the device of the invention over a longperiod of time, with the lined package acting to prevent undesirablemigration through the wall of the package in the manner which wouldundesirably shorten the shelf life of the structure of the invention.

Although the devices of the invention may be made in various sizes andshapes, as a particular example, the total lengths of any of the abovecontainers may be on the order of 1 inch while its diameter is on theorder of 0.3 inches. The cup shaped body 34 will have a total length onthe order of 1.5 inches and an outer diameter of approximately 1/2 inch,when used in the vagina.

What is claimed is:
 1. In a method for collecting fluids from the bodyof a human being or animal, the steps of positionally arranging anenclosure in juxtaposition to a cavity of the body which at least attimes contains body fluid in such manner that when the body fluid ispresent in the cavity the enclosure is in contact with the body fluid,said enclosure having within itself a hollow interior for receiving thebody fluid while shielding the body from the interior of the enclosure,creating between the interior of the enclosure and the body fluidconditions for only inward transfer of the body fluid into the interiorof said enclosure, the inward transfer of the body fluid into theenclosure commencing solely as a result of the contact with the bodyfluid, so that the collection commences automatically without externalactuation, and maintaining said inward transfer conditions effective atleast part of the time while the enclosure remains in contact with thebody fluid, so that thereafter when the enclosure is separated from thebody cavity, the desired body fluid will be situated in the interior ofthe enclosure.
 2. In a method as recited in claim 1 and including thestep of enclosing within the enclosure an agent which will provide thecollected body fluid with a given condition.
 3. In a method as recitedin claim 2 and wherein said agent includes at least as a part thereof anantibiotic for the purpose of preventing growth of certainmicroorganisms which may be present in the body fluid.
 4. In a method asrecited in claim 2 and wherein the agent includes at least as a partthereof a nutrient for promoting the growth of a certain microorganismwhich may be present in the collected body fluid.
 5. In a method asrecited in claim 4 and wherein said conditions for transfer of themicroorganism to the nutrient are created by a wick which fills anopening in a wall portion of the enclosure which is completely closedexcept for said opening which is filled by said wick, the latter havinga portion exposed at the exterior of said part of said enclosure tobecome situated at said location to engage a body fluid at said locationwhich may contain said microorganism, the nutrient being situated in theenclosure at an elevation below said wick so that the body fluid withthe microorganism, if it is present, therein will be carried by the wickinto the interior of the enclosure to form a drop which will fall fromthe wick to the nutrient.
 6. In a method as recited in claim 1 andwherein said enclosure is flexible and is formed at said part thereofwhich becomes situated in juxtaposition to the body cavity with a minuteopening such as a slit, said conditions for transferring the body fluidincluding the step of situating the enclosure in a compressed conditionwhere the interior of the enclosure has a substantially restrictedvolume, while releasing the enclosure for expansion when situated injuxtaposition to the body cavity to increase the interior volume of theenclosure while sucking the body fluid when it is present thereinthrough said minute opening.
 7. In a method as recited in claim 6 andincluding the steps of deforming the enclosure to maintain it in thecompressed condition of restricted interior volume while it is situatedin juxtaposition to the body cavity, and immediately thereafterterminating the deformation of the enclosure so that it willautomatically expand to draw the body fluid when it is present into theinterior of the enclosure through said minute opening or slit.
 8. In amethod as recited in claim 6 and including the step of preventingmovement of the collected body fluid in the enclosure outwardly of thelatter through said minute opening or slit.
 9. In a method as recited inclaim 6 and including the step of creating the compressed condition ofrestricted interior volume by a member which compresses the enclosureand is capable of dissolving in the body cavity for releasing theenclosure for expansion.
 10. In a method as recited in claim 1 andincluding the step of supporting the enclosure in a cup-shaped body ofsoft material to avoid discomfort from the presence of the enclosure atthe body cavity with said part of said enclosure being exposed at anopening of the cup-shaped body.
 11. In a method as recited in claim 1and wherein an agent which initially is in a dry condition is situatedin said enclosure for giving to the collected body fluid a predeterminedcondition.
 12. In a method as recited in claim 1 and including the stepof generating in the interior of said enclosure an atmosphere favorablefor the growth of a suspected microorganism which may be present in thecollected body fluid.
 13. In a method as recited in claim 1 andincluding the step of contacting the collected body fluid, withoutopening said enclosure, after the latter has been separated from thebody cavity, with a medium which will give to the collected body fluid apredetermined condition.
 14. In a method as recited in claim 1 andincluding the step of situating in said enclosure an agent in a drycondition and providing a wick which contacts said agent and whichprovides for a condition of transfer of a body fluid to said agent, andsituating the initially dry agent in the enclosure in an amountsufficient to prevent saturation of the agent during the entire timethat said enclosure remains at the body cavity.